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KMID : 0985420140360010030
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Laboratory Medicine and Quality Assurance
2014 Volume.36 No. 1 p.30 ~ p.38
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Performance Evaluation of the SelexOn Analyser for Seven Biomarkers
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Kim Hyun-Young
Lee Soo-Youn
Park Hyung-Doo
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Abstract
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Background:SelexOn (Infopia, Korea) is a novel immunoassay instrument that measures the concentration of α-fetoprotein (AFP), creatine kinase isoenzyme (CK-MB), D-dimer, high-sensitivity C-reactive protein (hs-CRP), myoglobin, prostate-specific antigen (PSA), and thyroid-stimulating hormone (TSH) in whole blood. We evaluated the analytical performance of SelexOn.
Methods:The analytical performance of SelexOn was evaluated for precision and linearity, and compared with the ADVIA Centaur XP Immunoassay System (Siemens, Germany) and the STA-R coagulation analyser (Diagnostica Stago, France).
Results:Within-run CV ranged from 2.9% to 8.9% for all biomarkers. Between-run precision ranged from 1.6% to 11.3% for all biomarkers, except at low levels of D-dimer (16.1%). Observed linearity ranges were AFP, 8.7 to 47.0 ng/mL; CK-MB, 4.7 to 38.7 ng/mL; D-dimer, 393.2 to 2,760.3 ng/mL; hs-CRP, 2.1 to 9.0 mg/L; myoglobin, 67.2 to 441.5 ng/mL; PSA, 2.6 to 23.7 ng/mL; and TSH, 3.3 to 38.9 mIU/L. Upon comparing SelexOn with the Centaur XP and STA-R systems, values of AFP, CK-MB, hs-CRP, and PSA showed good correlation, with correlation coefficients greater than 0.975. The correlation coefficients of TSH, myoglobin, and D-dimer were 0.9723, 0.9649, and 0.8379, respectively. The concordance was excellent for hs-CRP (kappa [κ]=0.958), PSA (κ=0.854), and TSH (κ=0.810); good for AFP (κ=0.655), CK-MB (κ=0.759), and myoglobin (κ=0.783); and moderate for D-dimer (κ=0.561).
Conclusion:SelexOn demonstrated acceptable precision, linearity, and correlation with the Centaur XP and the STA-R for seven biomarkers. Because of its speed and performance, SelexOn may facilitate the rapid screening of patients for cardiovascular disease, thyroid disease, prostate cancer, and hepatocellular carcinoma.
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KEYWORD
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Immunoassay, Cardiovascular diseases, Performance, Tumour markers
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